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A Randomized Controlled Study of Endoscopic Cryoablation Combined With PD-1 Inhibitor for Maintenance Therapy in Advanced Gastric Cancer

NCT06957977 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-05-06

No results posted yet for this study

Summary

This study evaluates the safety and efficacy of endoscopic cryoballoon ablation treatment (ECAT) combined with a PD-1 inhibitor (sintilimab) as maintenance therapy in patients with advanced gastric cancer, and further explores the underlying immunoregulatory mechanisms.

Conditions

Interventions

PROCEDURE

Endoscopic Cryoballoon Ablation Treatment

ECAT: A cryoballoon with catheter is inserted along the endoscopic forceps channel, the balloon is placed on the surface of the tumor, and the balloon is dilated so that it fits snugly over the lesion. The freezing cycle is initiated and continued for 2-3 minutes, and then the balloon is rewarmed and frozen again for 2-3 minutes; the freeze-rewarm cycle is repeated twice. PD-1:The first PD-1 monoclonal antibody treatment in this study was given within 3 days before and after ECAT treatment, and subsequent treatment was given every three weeks according to the instructions.

DRUG

PD1 Inhibitor

The first administration of the PD-1 monoclonal antibody is initiated when patients achieve a partial response (PR) following standard treatment. Subsequent administrations are given every three weeks according to the prescribing information.

Sponsors & Collaborators

  • Zhongguang Luo, MD

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2026-05-01
Completion
2027-05-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06957977 on ClinicalTrials.gov